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Ultrasound-Guided Landmark and Epidural Site Pain

Not Applicable
Completed
Conditions
Back Pain
Epidural Analgesia, Obstetric
Interventions
Procedure: US-epidural SVD
Procedure: US sham- epidural SVD
Procedure: Spontaneous vaginal delivery without an Epidural
Registration Number
NCT02813681
Lead Sponsor
The University of Texas Medical Branch, Galveston
Brief Summary

Historically, women who have chronic back pain after pregnancy have attributed the cause to the epidural procedure. While many studies have shown no greater incidence of generalized post-partum back pain in those who received an epidural, no studies have measured localized pressure sensitivity at the epidural insertion site. Short-term pressure sensitivity might limit patient's mobility and activities in the post-partum period. Understanding the factors that increase insertion site pressure sensitivity will allow the investigators to modify epidural placement technique in order to minimize this effect.

Detailed Description

Few studies have examined how epidural placement changes localized sensation at the epidural insertion site. This study will be the first study to quantitatively measure sensation at the epidural insertion site. The investigator will assess localized pressure sensitivity with an algometer. An algometer is a hand-held device commonly used by neurologist to detect sensory deficits and measures the pressure sensitivity threshold in a 1-cm diameter circular area. Ultrasound (US) pre-procedural examination provides more accurate landmarks for the placement of epidural catheters. The investigator will determine if an US examination prior to epidural placement reduces localized pressure sensitivity. The investigator will also determine if there are correlations between the participants characteristics and/or comorbidities and increased pressure sensitivity at the insertion site.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
80
Inclusion Criteria
  • pregnant with term (37 - 41 weeks) singleton gestation
  • active labor
  • history of normal pregnancy
  • request an epidural
  • age between 18 - 35 years old
  • able to understand the protocol and provide voluntary, written, informed consent.
Exclusion Criteria
  • history of spinal surgery
  • scoliosis
  • epidural or spinal placement within the last 5 days
  • neuropathic pain disorders
  • chronic opioid use
  • Texas Department of Criminal Justice patient
  • placental percreta
  • placental increta
  • placenta accreta
  • preeclampsia
  • eclampsia

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
US-epidural SVDUS-epidural SVDUS-epidural SVD group - participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity
(US sham- epidural SVD)US sham- epidural SVDUS sham- epidural SVD group- participants who received US examination process but with the monitor turned off.
SVD without an EpiduralSpontaneous vaginal delivery without an EpiduralSpontaneous vaginal delivery without an Epidural group The purpose of the control group is to serve as a baseline.
Primary Outcome Measures
NameTimeMethod
Epidural Pressure Sensitivity at Level of Epidural InsertionEpidural pressure sensitivity was monitored 10 minutes prior to epidural insertion and then for 10 minutes on each day after epidural removal for 3 days.

pressure sensitivity at level of epidural insertion will be measured with an algometer (Newtons)

Secondary Outcome Measures
NameTimeMethod
Induction MedicationThe chart review will determine the use of induction medication immediately prior to the epidural placement

The investigator will review the chart to see if the participant used of induction medication (answer yes will be recorded)

Short-term Back PainParticipants will be asked if they have had back pain for longer than a week immediately prior to epidural placement

The investigator will ask the participant if they have had back pain lasting longer than one week during pregnancy? (yes answer will be recorded)

Opioid Use During LaborA chart review of systemic opioids given to participant when the epidural is removed

The investigator will review the chart to see if the participant required opioids during labor (yes will be recorded)

Number of Needle RepositionsThe number of needle reposition will be counted during epidural placement.

The investigator will count the number epidural needle repositions during the epidural placement (whole number)

Number of Needle InsertionsThe number of needle insertions will be counted during epidural placement.

The investigator will count the number epidural needle insertions during the epidural placement (whole number)

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